It did, however, require marketers of “New Dietary Ingredients (NDIs)” to submit a premarket notification to the FDA at least 75 days before introducing it—unless the ingredient had a history of safe use before that date.

1997: FDA issues regulations for NDIs

2011 (January): The Food Safety Modernization Act passes. This required the FDA to clarify when an ingredient is considered NDI.

2011 (July): FDA publishes draft guidance

2017 (September): FDA issues draft guidance for comment

As the FDA explains, one purpose of this guidance is to improve compliance with the NDI notification requirement.

In 2012, FDA estimated that the number of dietary supplements on the market was 55,600 and that 5,560 new dietary supplement products come on the market each year. This is in contrast to the approximately 4,000 products that were on the market in 1994, when DSHEA was enacted.

As of December 2014, we had received and completed our evaluation of just over 750 NDI notifications since the first notification was received in 1995.

These figures, coupled with recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the importance of submitting NDI notifications as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles

The FDA also explains:

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

How are we to interpret this?

My take is that DSHEA is a public health disaster. It allows supplement companies to use pretty much whatever ingredients they want and to continue doing so until there is substantial evidence for harm.

This must be an attempt by the FDA to exercise some kind of control over ingredients in supplements. As such, the measure deserves support.

The Government Accountability Office (GAO) has a new report out calling for better federal oversight of memory supplements.

These are a growing market with sales estimated at $643 million in 2015, almost double since 2006.

FDA and FTC share oversight of memory supplement labeling and advertising, respectively, but neither approves claims in advance. For this, thank the Dietary Supplement Health and Education Act of 1994 which pretty much lets supplement makers claim whatever they like for their products, as long as they word the claims carefully.

GAO found ads for memory supplements claiming that they would boost, enhance, improve, increase, or maintain a healthy memory. They also made claims related to general brain health, cognitive function, and well-being.

Conclusion: Our results showed that, during a marked energy deficit, consumption of a diet containing 2.4 g protein · kg−1 · d−1 was more effective than consumption of a diet containing 1.2 g protein · kg−1 · d−1 in promoting increases in LBM [lean body mass] and losses of fat mass when combined with a high volume of resistance and anaerobic exercise.

Conflicts of interest: SMP has received research funding, travel allowances, and honoraria from the US National Dairy Council and Dairy Farmers of Canada. None of the other authors reported a conflict of interest related to the study.

Conclusion: This dose-response meta-analysis of observational studies suggests a possible role for dairy foods, particularly yogurt, in the prevention of T2D. Results should be considered in the context of the observed heterogeneity.

Funding: This meta-analysis project on dairy products and incident diabetes was funded by Wageningen University. SSS-M previously received funding from Global Dairy Platform, Dairy Research Institute, and Dairy Australia for projects related to dairy effects on lipoproteins and mortality; JMG previously received funding from the Global Dairy Platform and Dutch Dairy Association for projects related to dairy and cardiovascular diseases; and ELD previously consulted for the Dairy Research Institute. LG, VSM, and JdG reported no conflicts of interest related to the study. Any prior sponsors had no role in the design and conduct of the study, data collection and analysis, interpretation of the data, decision to publish, or preparation of this manuscript. The current funder had no role in design and conduct of the study, data collection and analysis, interpretation of the data, or decision to publish.

Comment: The conclusions put a positive spin on results that can also be considered equivocal.

Conclusion: These apparent benefits of milk and dairy foods have been attributed to their unique nutritional composition, and suggest that the elimination of milk and dairy may not be the optimum strategy for CVD risk reduction.

Conflicts of Interest: The authors have previously received funding for research from AHDB Dairy. J. A. L. has acted as an advisor to the Dairy Council. J. A. L. has received funding for research from Volac for BBSRC case studentship and ‘in kind’ foods from Arla for an MRC funded study.

Conclusions: Despite improvements in some nutritional markers, overall use of the vitamin and mineral supplement was less than prescribed. New methods are needed to guarantee delivery of micronutrients in children at risk of deficiencies as a result of an essential manipulation of diet in inborn disorders of metabolism.

Funding: Anita MacDonald has received research funding from Merck Serono, Vitaflo Ltd and Nutricia. She is on Advisory Boards for Arla, Merck Serono and Nutricia. Anne Daly and Sharon Evans have received research funding from Vitaflo Ltd, and Nutricia. Research funding was obtained from Vitaflo International for the funding of this project.

Today’s New York Times has a front-page story about how the FDA knew that certain weight-loss supplements contained unlabeled amphetamine-like substances but did nothing about it, perhaps because its head supplement official came from the industry (and has since returned to it).

Let’s start with the science.

In 2014, Pieter Cohen and his colleagues noted that several athletes had been disqualified from competition after tests found evidence of a methamphetamine analog (N,α-diethyl-phenylethylamine) in their urine. The athletes said that the chemical must have come from their workout supplements. Cohen et al. tested the supplements and identified the analog as one with entirely untested stimulant, addictive, or other adverse effects in humans. They recommended its immediate removal from all dietary supplements.

Earlier that year, the FDA reported that 9 of 21 supplements containing Acacia rigidula to test positive for varying amounts of another methamphetamine analog, β-Methylphenethylamine (BMPEA). The FDA investigators said this compound could be misidentified as amphetamine during certain kinds of analyses, but did not identify the products found to contain BMPEA.

The stimulant was present at quantities such that consumers following recommended maximum daily servings could consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements.

Recall that Congress passed the Dietary Supplement Health and Education Act in 1994, essentially deregulating the industry. The act allowed absurd health claims for supplements and essentially removed much of the FDA’s authority to regulate these products.

I still quaintly read the paper copy of the New York Times so I know that the left column of yesterday’s front page—judged by the editors as the second most important story of the day—was devoted to yet another exposé of supplement fraud.

The New York State attorney general did some sophisticated testing. His report concludes that major supplement retailers—GNC, Target, Walgreens and Walmart—are selling herbal supplements that do not contain what the labels say they contain or contain unlabeled ingredients that could be allergenic.

The examples are either amusing or shocking, depending on point of view:

A popular store brand of ginseng pills at Walgreens, promoted for “physical endurance and vitality”…contained only powdered garlic and rice.

At Walmart…ginkgo biloba, a Chinese plant promoted as a memory enhancer, contained little more than powdered radish, houseplants and wheat — despite a claim on the label that the product was wheat- and gluten-free.

Three out of six herbal products at Target — ginkgo biloba, St. John’s wort and valerian root, a sleep aid — tested negative for the herbs on their labels. But they did contain powdered rice, beans, peas and wild carrots.

And at GNC…it found pills with unlisted ingredients used as fillers, like powdered legumes, the class of plants that includes peanuts and soybeans, a hazard for people with allergies.

I’ve been writing about this kind of thing for years, but two aspects of this story are news.

First, the state is doing what the FDA ought to be doing if its hands weren’t tied by DSHEA, the Dietary Supplement Health and Education Act of 1994. That act essentially deregulated dietary supplements.

Second, these are not some fly-by-night supplement sellers. They are major retailers. The supplement industry’s argument that only a few unscrupulous small supplement makers are cheating on ingredients doesn’t work in this case.

Why don’t people stop taking supplements when they hear things like this?

The major proven benefits of supplements are their placebo effects. The actual ingredients make no difference.

The obvious conclusion is that if you must buy supplements, buy the cheapest ones. But that doesn’t work either because more expensive supplements produce stronger placebo effects.

Placebo effects are great things, and I’m for them. But caveat emptor.

The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) are therefore endorsing the following unified advisory for marketers and retailers, as well as for consumers of dietary supplements:

Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing Ebola virus disease, or preventing Ebola virus infection.

Marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for Ebola virus disease.

Anyone who believes they may have Ebola virus disease or may have come in contact with the Ebola virus should contact a healthcare professional immediately. The Centers for Disease Control and Prevention has more information on Ebola virus disease and the proper actions to take if you suspect you are ill.

The knowledge that no known treatment exists for Ebola has not stopped supplement manufacturers from advertising the benefits of their products for this infection.

FDA Warning Letters

The FDA has stepped in and issued warning letters to three manufacturers marketing their products as possible treatments or cures. The FDA letters, which make interesting reading, went to:

A simple Google search of “supplements Ebola” turned up this kind of information this morning:

The Ebola virus can be destroyed naturally – despite what you’ve been told To date, not a single virus has been tested that is not inactivated (killed) by a large enough dose of vitamin C (ascorbic acid). Many other antioxidants have similar virucidal effects, but vitamin C appears uniquely to be of greatest potency and clinical efficacy, as its simple chemical structure allows for it to be disseminated throughout the body with little restriction… Vitamin C is both very potent and optimally bioavailable in accessing any viral infection.

And this:

The substances in the Natural Allopathic protocol for Ebola offer a power unequalled in the world of medicinethat we can harness to save many lives of people infected with Ebola…. Magnesium salts, sodium bicarbonate (baking soda), iodine, selenium and vitamin C are concentrated nutritional medicinals that have been used in the direst of medical circumstances…The core of the Natural Allopathic protocol redefines the way emergency room and intensive care should be practiced on Ebola patients with proven fast-acting, safe, concentrated and mostly injectable nutritional medicines. If the Ebola infection truly gets out of hand, it is comforting for parents to know that they can legally administer these same medicinals if infected people are treated at home. All of the Natural Allopathic Medicines can be also taken orally or used transdermally (topically) to almost the same effect if treatment is started early enough.

How Can Supplement Makers Do This?

The ability of supplement manufacturers to claim health benefits for their products, and mostly get away with it, is a result of congressional action in passing the Dietary Supplement Health and Education Act of 1994 (DSHEA), which essentially deregulated these products.

Twenty years later, the supplement industry is deeply divided between responsible and irresponsible manufacturers, both allowed by law.

The industry of 1994, roughly $8 billion in sales, has experienced compounded double-digit growth every year since DSHEA became law…DSHEA opened the door to growth, innovation, new science, new discovery and a nation of wanting consumers enchanted with the thought that there are natural solutions to their individual health needs…20 years later, it’s time to take a hard look at what DSHEA doesn’t provide to the industry today. The barrier to entry into this industry continues to have no hurdles; DSHEA does not define the boundaries of consumer trust… The generations of today, and the generations of tomorrow will demand transparency, they will demand efficacy, and they will demand quality and safety from all of us.

EBOLA THREATENS WORLD’S CHOCOLATE SUPPLY: Ivory Coast, the world’s largest producer of cacao, the raw ingredient in M&Ms, Butterfingers and Snickers Bars, has shut down its borders with Liberia and Guinea, putting a major crimp on the workforce needed to pick the beans that end up in chocolate bars and other treats just as the harvest season begins… the outbreak already could raise prices…Prices on cocoa futures jumped from their normal trading range of $2,000 to $2,700 per ton, to as high as $3,400 in September over concerns about the spread of Ebola to Côte D’Ivoire.

Section 7606 of the 2014 Farm Bill says that notwithstanding the Controlled Substances Act, The Safe and Drug-Free Schools and Communities Act, and other laws that govern the cultivation of marijuana, it is now OK for state agriculture departments and universities to grow “industrial” hemp for research purposes.

Drug Enforcement Administration is offering few clues, insisting in public statements that while it is willing to allow marijuana sales in states that have legalized the drug, it might step in if growers try to sell beyond state borders…Any chemical that comes from the plant is still a controlled substance…When we get into hemp, it gets a little squishy, but it still is illegal.

At least one company is growing hemp in Colorado for use in dietary supplements. At a trade show last year, it displayed US Hemp Oil promoted for its content of CBD—cannabidiol, a non-narcotic fraction of the hemp plant.

The company insists that CBD is a legal ingredient of dietary supplements.

Hemp, it argues, is a vegetable:

The pure oil is considered GRAS [generally recognized as safe]. Under the United States Uniform Tariff Code they tax and code hemp as a vegetable. I don’t know anything that’s a vegetable that isn’t GRAS. When we import it, it is always considered a vegetable, so that’s what we use in our declaratory actions…in March of last year Canadian company Abattis announced plans to bring a CBD-infused kombucha drink to market.

However and whether CBD works for medical purposes, everyone expects industrial hemp to be a huge cash crop for its textile and health food uses.

The boon-for-Kentucky Website provides a long list of potential applications for industrial hemp, ranging from textiles to cosmetics to auto parts.

Proponents of CBD provide an even longer list of diseases for which industrial hemp’s CBD is a treatment option. There isn’t much research on the physiological effects of CBD. This makes industrial hemp perfect as a dietary supplements. It might do something. That’s all you need for supplement marketing.